Patients on non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2-selective NSAIDs, have reduced risk of gastric ulcers by taking NEXIUM® (esomeprazole magnesium). These results were from from two clinical trials and will be in the April 2006 edition of the American Journal of Gastroenterology.
NSAIDs include traditional, non-selective drugs, such as ibuprofen, naproxen and aspirin, and newer COX-2-selective agents.
The study which was a double-blind, randomized, six-month trial collected data and showed that significantly fewer patients taking either NEXIUM 20 mg or NEXIUM 40 mg, in addition to their regular non-selective NSAID/COX-2-selective therapy, developed an ulcer at six months, compared to those taking a placebo (5.2 percent and 4.6 percent, respectively, vs. 17 percent, p<0.001).
James M. Scheiman, MD, Division of Gastroenterology, Department of Internal Medicine, University of Michigan said, "Paradoxically, NSAID use is common among patients at high risk for gastric ulcers or other complications associated with these medications. Although COX-2-selective drugs generally cause fewer gastric ulcers than non-selective NSAIDs, these events aren't completely eliminated, and the residual side-effect rate still may be high. Data from the two trials showed that NEXIUM was effective in reducing stomach ulcers in at-risk patients who require chronic NSAID treatment."
Data from the two studies which were double-blind, randomized, placebo-controlled trials involved a total of 844 (U.S.) and 585 (multinational) patients. They were randomly assigned in a 1:1:1 ratio to treatment with either NEXIUM 20 mg, NEXIUM 40 mg or a placebo. Patients were continuous NSAID users (i.e., receiving daily non-selective NSAID or COX-2 therapy for at least four weeks before and throughout the duration of the six-month trial) at risk of developing a gastric or duodenal ulcer as a result of older age (>60 years) and/or a history of previous gastric ulcers.
The results were noted and analyzed for the study.